MAUDE Adverse Event Report: DORNOCH ULTRA DUO HIGH FLUID CART CONTAINS: SMOKE EVAC; ULTRAFLEX¿ DUO #UL-DU500SE

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2015

Event Type  malfunction  

Manufacturer Narrative

The investigation of the device was not completed at the time of this report.A follow up medwatch will be submitted once the investigation is complete.

Event Description

It was reported that the technician recently replaced a level sensor and the level sensor did not seat properly in the cart.During the first case on machine, biomass from case leaked out of bottom level sensor into the bottom of the cart and onto operating room floor.Per the customer, the cart was leaking biofluid during the surgical procedure.The cart was clean/empty prior to the case (the fluid was from an individual patient) and the fluid leaked onto the operating room floor (there was no backflow into the patient).There was no patient harm or injury and there was no injury to any of the or staff.

Manufacturer Narrative

The reported event ¿that a (b)(4) repair technician recently replaced the level sensor which did not seat properly in the cart, thus leading to a biomass leak from the bottom of the level sensor.The leak entered into the bottom of the cart and then onto the operating room floor¿ was noted in microsoft customer relationship management (crm).Exchange of the device was performed by a (b)(4) representative on 12/4/2015.Ultra duo smoke evacuation unit (ul-du500se), serial number (b)(4), was exchanged with ultra duo refurbished unit (ul-du500r), serial number (b)(4).The new cart was installed and tested per installation instructions and documented on the installation checklist.The (b)(4) representative packaged and boxed ul-du500se, serial number (b)(4), for return.The root cause of the biomass leak could not be specifically determined since it was not able to be concluded upon investigation where the leak originated from.It is possible that the leak originated from the level sensor in cylinder 2 since scratch marks on the sensor indicated that it may not have been seated properly and moved when under vacuum, as noted in the returned parts investigation report (rpir).However, there is a greater possibility that the leak stemmed from the level sensor in cylinder 1 not being seated correctly since this sensor had been installed the day before, and the reported event happened during the first use of the cart after repair.Events of this nature will be tracked to determine what, if any, additional actions are necessary.Ul-du500se, serial number (b)(4), was exchanged with ul-du500r, serial number (b)(4).Recommended actions from ¿dornoch transposal ultra cart instructions for use manual¿ gd-99022 rev.H, effective july 23, 2014: do not use this system outside the scope of the defined indications for use.

• Brand Name: ULTRA DUO HIGH FLUID CART CONTAINS: SMOKE EVAC
• Type of Device: ULTRAFLEX¿ DUO #UL-DU500SE
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer (Section G): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer Contact: jennifer hutchison ; 200 northwest parkway; riverside, MO 64150 ; 8165052226
• MDR Report Key: 5330760
• MDR Text Key: 35036050
• Report Number: 0001954182-2015-00007
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULDU500SE
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1